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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03879499
Other study ID # 2017/78
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date January 1, 2018

Study information

Verified date March 2019
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

After laparoscopic hysterectomy, authors aimed to determine cuff hematoma and a postoperative CRP value to help predict the other complications.

A total of 136 patients who underwent total laparoscopic hysterectomy (TLH) were evaluated. CRP, White blood cell (WBC) and hemoglobin values (Hb) were measured on the 1st, 2nd and 7th days before and after the operation. Complications, pre-postoperative vaginal length and female sexual function were evaluated. Fourteen patients who developed cuff hematoma during postoperative follow-up were analyzed with the receiver operating characteristics (ROC) curve. ROC curves with the largest area under the curve for each inflammatory marker were compared in order to define the marker with higher diagnostic accuracy.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date January 1, 2018
Est. primary completion date January 1, 2018
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:women who underwent TLH operation with benign gynecological indications

Exclusion Criteria:

- Decided to switch to laparotomy during operation

- postoperative complication due to relaparotomy

- infection (including urinary system and lung infections)

- Blood transfusion after TLH

- with rheumatic diseases

- length of hospital stay due to wound infection

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Relationship between CRP Levels and cuff hematoma; crp levels The value of Postoperative CRP Levels to predict Postoperative Vaginal Cuff Hematoma ; To evaluate tissue trauma and surgical inflammatory responses, venous peripheral blood samples (C-reactive protein) were taken on the first, second and seventh day postoperatively. CRP values were measured under standardized conditions using turbidometry. CRP levels (mg / dl) were recorded. 1 week
Primary Relationship between CRP Levels and cuff hematoma; cuff hematoma measurement The patients were called to the outpatient clinic after the hysterectomy and evaluated by transvaginal ultrasonography (tvusg) for cuff hematoma.hematoma dimensions recorded in centimeters. 15 days
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